A Double-blinded, Randomised, Three-period Crossover Euglycaemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Human Insulin, Human Insulin (Huminsulin® Normal) and Insulin Lispro (Humalog®) in Subjects W

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

The addition of BioChaperone to already marketed prandial human insulin preparations may accelerate the onset and shorten the duration of action due to facilitation of the insulin absorption after subcutaneous injection.

The aim of the trial is to assess the efficacy and safety of BioChaperone human insulin in subjects with type 1 diabetes under a dose of 0.2 U/kg.

This trial is a single center, randomised, double-blinded, three treatment, three-period cross-over, 10-hour euglycaemic clamp trial in subject with type 1 diabetes mellitus. Each subject will be randomly allocated to a single dose of BioChaperone human insulin 0.2 U/kg, a single dose of Huminsulin® Normal 0.2 U/kg and a single dose of Humalog® 0.2 U/kg on 3 separate dosing visits.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Adocia
• Treatments: Insulin; Insulin Lispro; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Male subject with type 1 diabetes for at least 12 months

• Treated with multiple daily insulin injections or insulin pump (CSII) for at least 12 months

• Body mass index: 18.5-28.0 kg BW·m-2

• HbA1c: ≤ 9.0%

Exclusion Criteria:

• Diabetes mellitus type 2

• Receipt of any investigational product within 3 months prior to first dosing of investigational product in this trial

• Clinically significant abnormalities as judged by the Investigator

• Any systemic treatment with drugs known to interfere with glucose metabolism

• History of alcoholism or drug/chemical abuse as per Investigator's judgement

• Use of any tobacco or nicotine-contained product within one year prior to screening